Study of a Suprachoroidal Retinal Prosthesis

Retinitis Pigmentosa Clinical Trial

Official title:

Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406416
• Other study ID #: BVT_001
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 18, 2020

Study information

• Verified date: August 2021
• Source: Mobius Medical Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.

Description:

Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older

• Either gender

• A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia

• Remaining visual acuity of bare light perception or less in both eyes

• Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response

• A history of at least 10 years of useful form vision in the worse seeing eye

Exclusion Criteria:

• Optic nerve disease (history of glaucoma of More than 1 month, or history of any other optic neuropathy)

• Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease.

• Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions)

• Any ocular condition that predisposes the participant to rubbing their eyes

• Cognitive deficiencies, including dementia or progressive neurological disease

• Psychiatric disorders, including depression, as diagnosed by a qualified psychologist

• Deafness or significant hearing loss

• Inability to speak or understand English

• Pregnancy

• Presence of a cochlear implant

• Participant enrolled in another investigational drug or device trial for the treatment of their ocular condition

• Poor general health, which would exclude them from obtaining a general anaesthetic

• Unrealistic expectations of the investigational device to provide functional vision

• Poorly controlled diabetes

• Epilepsy

• Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained)

• Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference

Related Conditions & MeSH terms

• Choroideremia
• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• 44Ch Bionic Eye Device
Prototype wide view suprachoroidal retinal prosthesis

Locations

Country	Name	City	State
Australia	Centre for Eye Research Australia	Melbourne	Victoria

Sponsors (7)

Lead Sponsor	Collaborator
Mobius Medical Pty Ltd.	Australian National University, Bionic Vision Technologies, Bionics Institute, Centre for Eye Research Australia, Data 61 CSIRO, University of Melbourne

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Ayton LN, Blamey PJ, Guymer RH, Luu CD, Nayagam DA, Sinclair NC, Shivdasani MN, Yeoh J, McCombe MF, Briggs RJ, Opie NL, Villalobos J, Dimitrov PN, Varsamidis M, Petoe MA, McCarthy CD, Walker JG, Barnes N, Burkitt AN, Williams CE, Shepherd RK, Allen PJ; Bionic Vision Australia Research Consortium. First-in-human trial of a novel suprachoroidal retinal prosthesis. PLoS One. 2014 Dec 18;9(12):e115239. doi: 10.1371/journal.pone.0115239. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of device related serious adverse events (SAEs)	The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.	2 years
Secondary	Efficacy - visual response	The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.	2 years
Secondary	Visual Function and Functional Vision	Visual function and Functional Vision will be scored from performance on a range of acuity, orientation and mobility, and activities of daily living tasks. Outcome measures include: Grating visual acuity: record the grating acuity level and average response time.; Square localization: response error and response time is measured.; Motion detection: response error and response time is measured.; Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded.; Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded.; Obstacle avoidance task: task time and number of collisions is recorded.; Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.	2 years
Secondary	Quality of life - IVI - very low vision validated questionnaire	Quality of life will be assessed via survey and self-report. The Functional Low Vision Observer Assessment (FLORA) is a questionnaire that will be used to measure participants changes in participant daily living experiences.	2 years